Paragraph 7 F1
In Annex 6—
in Section 1, for “authorised representative established within the Community” substitute “UK responsible person”;
in Section 3 for “the competent national authorities” substitute “the Secretary of State”;
in Section 3.1 for “this Directive” substitute “the Regulations”;
in Section 3.2 for the fourth indent substitute—
“–the results of the risk analysis and a list of the designated standards provided for in regulation 3A of the Regulations, applied in full or in part, and a description of the solutions adopted to satisfy the essential requirements where the standards in regulation 3A of the Regulations have not been applied,”;
omit Section 5.
Annotations
Textual amendments
- F1
Sch. 2A inserted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 12 (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 56, 57); 2020 c. 1, Sch. 5 para. 1(1)
- F2
Sch. 2A para. 7(e) substituted (17.6.2025) by The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 (S.I. 2024/1368), regs. 1(2), 5(5) (with reg. 6)